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The risks of counterfeit imported medicines

A recent Wall Street Journal article laid out the serious concerns posed by potent, counterfeit prescription opioids pouring into the United States from China, Mexico and Canada. The Drug Enforcement Administration (DEA) and other U.S. law enforcement face a growing challenge in preventing counterfeit fentanyl from reaching the United States. Fentanyl is exponentially more powerful than morphine and heroin. Its use is generally limited to use in the management of breakthrough pain in cancer patients – but now hundreds of thousands of pills produced in China are illegally flowing into the United States through Canada and Mexico. Given that some law enforcement officers have said counterfeit fentanyl has greatly exacerbated the current opioid crisis, we cannot afford to endanger more lives through ill-conceived drug importation schemes.

The reality is that by opening our drug supply, we could see even more counterfeit, unapproved and adulterated drugs enter the United States and threaten patient safety. The importation of unapproved and potentially counterfeit medications is risky, dangerous and even fatal as medicines can contain incorrect dosages, be laced with dangerous substances or be the wrong treatment all together. Over the years, we’ve seen counterfeit cancer drugs as well as opioids enter the United States illegally with deadly consequences. Proposed importation schemes would increase the potential for counterfeit or adulterated products to infiltrate the U.S. pharmaceutical supply chain as these schemes are very broad in scope, and they would allow drugs not approved by the U.S. Food and Drug Administration to enter the United States – all while not providing enforcement or other mechanisms to ensure the safety of what may flow into the United States from other countries through Canada.

Recently, the CEO of the U.S. Pharmacopeial Convention stated,“There is no system in place to assure the safety and quality of medicine that was not intended for the U.S. market if [it] is exported to the U.S. from Canada. Canadian regulators focus on — and are only resourced to regulate — drugs dispensed to Canadians, not on drugs that are exported to the U.S. That is not so surprising, actually. Could you imagine the U.S. Congress authorizing new proposals to spend money protecting Canadian patients?”

And, to put a finer point on the challenge of illegal opioids entering the country, the executive director of the National Association of Drug Diversion Investigators stated, “While medications purchased from legitimate U.S.-based pharmacies are safe, huge quantities of opioids consumed and abused in the United States are procured illegally and produced illicitly, often in other countries and in violation of U.S. law. A large portion of the increase in deaths resulted from illegally manufactured drugs coming from far corners of the globe.”

Allyson Funk Ally is a former senior director of public affairs at PhRMA focused on advocacy issues for the biopharmaceutical industry. Her expertise includes Medicare, Medicaid, 340B, health reform and more. Prior to PhRMA, her experience included leading health communications for a large membership organization, supporting public affairs clients and working for the governor of Louisiana.